HHS Sets End Dates for COVID-19 Emergency Use Declarations Covering Devices and Drugs

The US Department of Health and Human Services has set end dates for the emergency use authorization declarations that have underpinned COVID-19 tests, respirators, other medical devices and treatments since 2020, according to two notices published in the Federal Register on July 2. The HHS Secretary determined on June 29 that circumstances no longer exist to justify emergency use of these products, the notices say.

The device notice terminates three declarations, effective December 26, 2026: for in vitro diagnostics for detection or diagnosis of SARS-CoV-2, issued February 4, 2020; for personal respiratory protective devices, issued March 2, 2020; and for medical devices including alternative products used as medical devices, issued March 24, 2020. The drug and biologics notice terminates the March 27, 2020, declaration for drugs and biological products, effective June 29, 2027. AHA News reported on June 30 that HHS had announced the terminations that day.

Why HHS says the devices declarations can end

The device notice says demand for COVID-19 diagnostics, respiratory protective devices and other devices has fallen significantly, and that "There are now over fifty COVID-19 tests that have been granted traditional marketing authorization and demand for COVID-19 tests has significantly reduced." It says adequate numbers of device types that had been covered by the broad devices declaration, such as blood purification and hemodialysis devices, remote or wearable patient monitors, respiratory assist devices and ventilators, have been authorized through traditional pathways. FDA continues to encourage manufacturers to obtain authorization through traditional premarket pathways as appropriate, the notice says.

The December date follows a transition policy FDA set out in final guidance in March 2023, which said HHS intends to publish advance notice 180 days before a device declaration ends and recommended that makers of EUA devices plan their post-EUA regulatory and disposition strategies. The notice says FDA will separately give notice of termination of the individual EUAs issued under each declaration.

A 12-month transition for drugs and biologics

For drugs and biologics, the notice says the EUAs for COVID-19 vaccines and convalescent plasma have been revoked, that licensed versions of those products are available, and that there are FDA-approved therapeutic options for all ages and across the spectrum of disease. HHS said 12 months is a reasonable period for sponsors to generate data that could support a new drug or biologics license application.

During that period, FDA intends to decline to review and process new EUA requests for COVID-19 drugs or biological products, while still reviewing amendments to existing EUAs that are necessary or appropriate to protect public health, according to the notice. If there is a gap between the end of an authorization and an FDA approval, sponsors can work with FDA on access through clinical trials and expanded access protocols, it says.